Judgement

RANGANATH MISRA, J. :- The petitioner, an advocate by profession is the General Secretary of Public Interest Law Service Society, Cochin. In his application as amended on 7th Feb., 1983, under Art. 32 of the Constitution he has asked for directions, in public interest, banning import, manufacture, sale and distribution of such drugs which have been recommended for banning by the Drugs Consultative Committee and has also asked for cancellation of all licences authorising import, manufacture, sale and distribution in respect of such drugs. He has also asked for a direction to the Central Government to constitute a high-powered Authority to go into the hazards suffered by people of the country on account of such drugs being in circulation and suggest remedial measures including award of compensation. He has further prayed that directions should be given for framing of strict regulations to ensure the quality and standard of approved drugs and to ensure weeding out of same, harmful as also injurious drugs from the market. The petitioner has alleged that the drug industry in India is dominated by multi-national Corporations originally based in U.S.A., U.K., Federal Republic of Germany, Swedon, Japan, France and the like. According to the petitioner these Corporations have large resources and make huge profits. The control exercised by the Government in this country on such Corporations is minimal and inadequate. The disease-prone sub-continent of India has been used as pasture ground by these Corporations. The Hathi Committee appointed by the Central Government in its Report submitted in 1974, highlighted the havoc played by these Corporation in the Indian scene and pleaded. or nationalising the drug industry in the best interest of the Indian people. The recommendation has not been accepted by the Government. According to the petitioner several drugs banned in the advanced west after appropriate analytical research are routed into India and on account of lack of control and sluggish enforcement of the law conveniently find their way into the market. What is poison to the human body in the west is equally poison to people in India but not knowing the repercussion thereof on the human system, such drugs freely circulate and are even prescribed for patients.

2. The Central Government announced its drug policy in 1979 and set a guideline covering the relevant aspects of the trade. According to the petitioner no attempt has been made to give effect to the policy and there has really been no enforcement. The objectives outlined therein have remained on paper. Though the policy indicated that Government intended to develop indigenous drug technology so as to become self-sufficient, no effective steps have been taken in this direction. The poor illiterate people of India are often misled and misguided as they are not aware of the evil effects of certain drugs available in the market and often become a tool in the hands of quacks and inexperienced doctors. Often they fall a victim to publicity and not knowing how dangerous the result of taking the particular drug could be they take it. According to the petitioner, almost half of the drugs used in India are still being imported into the country, notwithstanding indigenous manufacture both by local as also the multi-national Corporations. The petitioner has contended that modern drugs reach only one-fifth of the Indian population. According to him, the drug industry is totally profit-oriented and no care or attention is bestowed upon good health of the citizens of India.

3. In 1980, the Drug Consultative Committee set up a Sub-Committee of experts for screening the formulations of drugs prevalent in the Indian market from the point of therapeutic rationale in order that irrational and harmful combinations of drugs could he banned. The said Committee of experts recommended banning of twenty fixed dose combinations of drugs. According to the petitioner, 400-500 drugs with different trad